Tart Cherry, Metabolic Syndrome, and Cardiovascular Risk

NCT02154100 | Completed Phase 2

• 1 other identifier: RF02406
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

The hypothesis of this study is that the daily consumption of 480 ml tart cherry juice for twelve weeks will improve blood pressure and arterial stiffness by improving endothelial-mediated vasodilation and vascular sympathetic activity and favorably altering biochemical markers associated with cardiovascular risk. 28 men and women between the ages of 20 and 40 who have three of the five features of metabolic syndrome as defined by the Adult Treatment Panel III will be included in the study. After a two-week run-in phase, eligible men and women will be randomly assigned to one of two treatment groups: 1) 480 ml tart cherry juice or 2) 480 ml control drink daily for twelve weeks. After an initial telephone screening, all participants will be requested to report to the study site for their first visit. On the first visit (screening), participants will be provided with verbal and written explanation of the project. They will then be asked to sign an informed consent form, followed by measuring waist circumference, resting brachial blood pressure, fasting serum triglycerides, high density lipoprotein cholesterol, and glucose levels to confirm metabolic syndrome. Baseline assessments will be performed for medical history, medication use, dietary intake, and physical activity. Qualified participants will be scheduled for their second visit two weeks later (actual baseline data collection) and randomly assigned to their treatment group. On the second (baseline) visit between the hours of 7-10 A.M., blood pressure and vascular function will be measured followed by blood draw. Anthropometrics will be measured. Participants will be provided with their assigned treatment and will receive standard instructions on how to fill out daily diaries for their treatment, and for food and physical activity records. Blood pressure, vascular function, blood draw, and anthropometric, body composition, diet, and physical activity assessments will be repeated at 6- (third visit), and 12-week (final visit) intervals. All cardiovascular measurements will be performed between 7:00 to 10:00 A.M., in a quiet temperature-controlled room in the supine position after an overnight fast and 12 hours after the abstinence of caffeine and/or 24 hours after the last bout of moderate to heavy physical activity.

Conditions

Metabolic Syndrome; Cardiovascular Diseases; Diabetes

Keywords

Metabolic Syndrome; Arterial Stiffness; Blood Pressure; Endothelial Function; Tart Cherries

Outcome Measures

Primary Outcomes (2)

• Blood Pressure

  By measuring brachial and aortic blood pressure at rest and during physiological stress (handgrip exercise and post-exercise muscle ischemia).

  12 weeks

• Arterial Stiffness

  By measuring arterial stiffness and augmentation index at rest and during physiological stress (handgrip exercise and post-exercise muscle ischemia).

  12 weeks

Secondary Outcomes (8)

• Autonomic Control of Blood Pressure

  12 weeks

• Endothelial Function

  12 weeks

• Endothelial-mediated Vasodilation

  12 weeks

• Inflammation

  12 weeks

• Oxidative Stress

  12 weeks

Study Arms (2)

Tart Cherry

EXPERIMENTAL

12 weeks of tart cherry juice taken in two doses of 240 ml per day.

Dietary Supplement: Tart Cherry

Placebo

PLACEBO COMPARATOR

12 weeks tart cherry juice taken in two doses of 240 ml per day.

Dietary Supplement: Placebo

Interventions

Tart Cherry DIETARY_SUPPLEMENT

12 weeks of tart cherry juice taken in two doses of 240 ml per day.

Tart Cherry

Placebo DIETARY_SUPPLEMENT

12 weeks of tart cherry juice taken in two doses of 240 ml per day.

Placebo

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Three of the following five features at the screening visit:
• Waist circumference of ≥ 40 inches for men and 35 inches for women
• Serum triglycerides ≥ 150 mg/dL
• Serum high density lipoprotein cholesterol levels \< 40 mg/dL for men and \<50 mg/dL for women
• Blood pressure ≥ 130/85 mm Hg
• Fasting blood glucose level ≥ 110 mg/dL

You may not qualify if:

• Taking hypoglycemic, antihypertensive or cholesterol-lowering medications
• Diagnosed cardiovascular disease
• Uncontrolled hypertension (≥ 160/100 mmHg)
• Diabetes mellitus
• Other active chronic diseases such as cancer, asthma, glaucoma, thyroid, kidney, liver and pancreatic disease
• Participating in a weight loss program
• Heavy smokers (\> 20 cigarettes per day)
• Heavy drinkers (\> 12 alcoholic drinks per week)
• Abnormal menstrual cycle

Sponsors & Collaborators

• Florida State University: lead
• Cherry Research Committee: collaborator

Study Sites (1)

Department of Nutrition, Food and Exercise Sciences, Center for Advancing Exercise and Nutrition Research on Aging, Florida State University

Tallahassee, Florida, 32306, United States

Location

MeSH Terms

Conditions

Metabolic Syndrome; Cardiovascular Diseases; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Bahram H. Arjmandi, PhD, RD

  Department of Nutrition, Food and Exercise Sciences, Center for Advancing Exercise and Nutrition Research on Aging, Florida State University

  PRINCIPAL INVESTIGATOR

• Arturo Figueroa, MD, PhD

  Department of Nutrition, Food and Exercise Sciences, Florida State University

  PRINCIPAL INVESTIGATOR

• Sarah A. Johnson, PhD, RDN

  Department of Food Science and Human Nutrition, Colorado State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 30, 2014
• First Posted: June 3, 2014
• Study Start: April 1, 2014
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: December 8, 2016

Record last verified: 2016-12

Locations

US (1)